Q & A with Lynn Padley, MA, MT(ASCP)
Administrator, Quality Management Services and Practice,
Department of Laboratory Medicine and Pathology, Mayo Clinic
Medical Lab Management: Where in the test cycle do errors most commonly occur?
Lynn Padley: Based on my experience and what I have read in the literature, the most common errors are specimen identification errors, which can occur at any point in the test cycle. However, most errors generally occur at the time of specimen collection or at the time the specimen is labeled. Thus, a specimen can be misidentified before it ever arrives in the laboratory. Keep in mind, properly identifying samples in anatomic pathology is somewhat more complex than clinical pathology given that when tissue samples are taken from the body, there can be multiple tissue sample types, and the specific source location of those samples can be very important to how the pathologist will render an interpretation. For example, in clinical pathology, if you draw a tube of blood, in most cases and for all practical purposes, that blood is the same throughout the body, so identification of that sample is as basic as linking it to its source patient. Alternatively, if a biopsy is performed on a particular area or organ, it is very important to know exactly where the sample came from.
MLM: Which errors are most likely to result in patient harm?
Padley: From an anatomic pathology standpoint, identification of proper patient and specimen location are equally important. Further to this, and likewise vital to error reduction and avoiding harm is the concept of laterality. If a biopsy is performed on breast or kidney tissue, for example, it must be clear which breast or which kidney is being examined. Among the most severe implications would be to diagnose a malignancy and then have a mischaracterized identification lead to a wrong site surgery. As such, the impact of errors with anatomic pathology can be quite dramatic.
Another error that can lead to significant patient harm involves the transmission of information throughout the testing and reporting process. Many institutions have experienced information continuity issues depending on the LIS system in use. If a technician or medical secretary is working on patient John Smith’s case and begins entering diagnosis information into Jane Smith’s report, this also can lead to adverse events if not caught by the clinician. This type of human error underscores the importance of all individuals in the testing process taking responsibility to review and understand all the materials they have in front of them, and this includes consistent, standardized labeling. Ensuring uniform identification helps enable accurate, clear, and precise reporting.
A key benefit to anatomic pathology is access to clinical information to aid in test interpretation. Invariably, diagnoses are correlated with clinical information and knowing precisely what it is the clinician is looking to determine is essential to error mitigation. If the pathologist has been instructed to look for a malignancy in a breast tissue sample and instead sees colon tissue, it should be instantly evident that a mistake has occurred. Thus, there are built-in controls within the process as a result of that correlation.
MLM: In your experience, what strategies are the most successful in reducing risk?
Padley: One of the luxuries of having a large anatomic pathology staff is the availability of multiple experts who can offer second opinions and provide another opportunity to detect errors. At Mayo Clinic, we have a laboratory trainee program involving residents and fellows who review cases before going to the pathologist, which provides an additional safety layer. While having multiple expert reviews can help mitigate risk, such actions also must be economized. Simply adding more review layers to the testing analysis process is not the solution to eliminating risk because those additional layers translate into additional cost and require more time. In today’s cost- and waste-conscious health care environment, we have to be careful before we advocate for additional checks or additional layers for the sake of trying to catch errors. What can often happen in this case is that some parties become complacent, assuming that any errors would have been detected earlier in the review. If every person in the process makes that assumption, then no one is actually performing an adequate review.
From a fundamental quality assurance standpoint, we have to recognize and understand the limitations of human ability to detect errors and move toward more system-based approaches to error prevention. These systems can include standardization of processes, as well as electronic solutions such as leveraging bar coding technology to remove as much human factor risk as possible from a given process.
MLM: What steps can be taken to ensure quality controls are designed into processes?
Padley: In Mayo Clinic laboratories, we have taken great strides in making our processes more lean, which largely involves reducing or eliminating waste. It is a given that in systems involving multiple interactions and movement of materials, errors are more likely to occur at the transition points. Thus, we have found that efficient streamlining frequently comes about through minimizing the number of handoffs, which helps reduce opportunities for error. Likewise, it is important to review how specimens and their attendant information are moving through the system. This will help standardize workstations and make sure staff members are processing the workflow in the same ways. Another option is establishing a system whereby an employee works with only one patient or one sample at a time, thereby minimizing the opportunity to mix up cases. However, there should be sufficient variety to the range of tasks or cases to avoid complacency.
Furthermore, by fostering an efficient environment, there is a reduced temptation for staff to find process work arounds. It can be a challenge to design processes that have staff performing one action at a time, so seeking balance between a batching mentality and singular work tasks becomes important. In the attempt to enable this balancing, one approach is to have technologists alternate tissue types. In the previous example of a potential mix up of breast tissue and colon tissue, a technologist would be much less likely to detect an error in that scenario if all the cases he or she worked on were breast cases. So, one recommendation would be to alternate casework such that a technician works on a breast case followed by a colon case, a prostate case, and so on. This rotation will not inherently reduce errors, but it creates an opportunity to detect errors that might otherwise not be available.
MLM: What is the value of conducting periodic quality and safety meetings in anatomic pathology?
Padley: It is certainly common for anatomic pathology staff to have weekly quality and safety meetings to review any events or errors that occurred in the preceding week. Not all errors are examined, as some are straightforward such as a misidentified specimen that was caught it before moving through a test cycle, but it is beneficial to tabulate those errors to see what areas might be having issues.
Errors that do warrant further examination are those that passed through the process to the report or patient level without being caught. Those errors should be reviewed carefully to identify, as a group, any common trends or patterns that could be addressed from a system perspective. Any errors that posed legitimate risk to patient safety also should be viewed in aggregate to determine the best course of prevention. Does the data support the purchase of technology or automation to correct the source of error? Do these errors stem from a lack of standardization or is there a deficiency in training?
This last point has its own set of qualifying factors, as it can be easy to conclude that retraining will solve errors in human-dependent interactions. However, if the problem stems from a system issue, as opposed to a personnel issue, then all the retraining in the world will not solve the problem and instead will just create more work and more waste. Conversely, adding an automated component to a process could deliver significant benefits. For example, at Mayo Clinic, we are in the process of implementing bar coding on blocks and slides to help eliminate potential mix-ups of specimens. The bar codes are generated by the histotech at cutting, which enforces the concept of working on one case at a time.
Lastly, it is important to convene intradepartmental meetings between clinicians and pathologists to perform case reviews. These meetings are held in concert with the above-mentioned pathology meetings to dig deeper into methods and reasons for test interpretations and diagnoses. Albeit rare, these intradepartmental meetings also offer opportunities to detect errors in interpretation or methodology. This is valuable because if a test interpretation cannot be reconciled with actual clinical interaction with the patient, safety can be jeopardized.
MLM: What are best practices for conducting patient safety audits in anatomic pathology?
Padley: We have found it productive to have an internal audit team at the department level that will perform audits across the entire department, but within anatomic pathology, routine audits of certain areas are executed in order to hone in on the source of specific problems. Despite differences in the relative sizes of hospital lab operations, there remains a common regulatory expectation to maintain some level of internal audit activity, so smaller practices likely need to be more creative in accomplishing this. Collaborating with another small practice to perform objective audits at each other’s facility is one option; engaging a consultant to come in on a periodic basis to evaluate processes is another route.
While there are opportunities to find workable solutions, it is easy to recognize that the limited resources of smaller practices can make it very challenging to conduct comprehensive audits and reviews. Looking at it another way, smaller practices tend to see fewer patients and may have more time to audit any errors and less of a range of departments and services to review.
MLM: How can anatomic pathology identify and apply good risk assessment and risk management tools?
Padley: The use of risk assessment and management tools is probably not as common as it should be in anatomic pathology and structured investigations, such as failure modes and effects analysis (FMEA), can be quite helpful. Many times, though, these are only performed when implementing a new process, whereas they also can be beneficial in evaluating existing processes. Frankly, the whole concept of risk assessment and management is relatively new in the laboratory arena, and while many practitioners think in these terms, actual programs are not as formalized as they could be. There is certainly an opportunity to implement those tool sets more broadly and more effectively.
While the FMEA process is the most common and probably the most familiar to health care practitioners, there are other options. Among them is the Quality Management System provided by the Clinical and Laboratory Standards Institute.1 This document includes written and graphic descriptions of fundamental processes and common supporting elements in a continual improvement program.
MLM: How can you ensure staff is actively identifying errors or risk for errors in their processes?
Padley: One theoretical movement we have placed emphasis on at Mayo Clinic is incorporating the concept of a fair and just culture into our approach to managing errors. We want to be sure our staff feel comfortable speaking up if they identify something that has gone wrong, even if it is something they were responsible for themselves. This is not about pointing fingers; rather, it is about identifying weaknesses in our processes and allowing us to strengthen those areas from a patient’s perspective. In general, we are trying to remove the concept of blame from error and risk prevention, particularly in light of the fact that the majority of errors made in laboratory processes are due to system failures and not human error.
Regardless, your facility must have tools for dealing with situations where human error is the cause of the issue and if errors are the result of behavioral actions, as opposed to a system failure, then it likely stems from one of the following reasons:
- A staff member did not have sufficient working knowledge to perform his or her assigned tasks
- That staff member had every intent of performing the task as expected, but an unaccounted disruption led to error
- That staff member was behaving in a reckless manner where the intention was good, but he or she made a poor judgment in attempting a work around or a shortcut
- That staff member specifically knew his or her actions were wrong, yet went ahead anyway
Accordingly, management must be prepared to address each of these scenarios and understand when errors are borne from a behavior issue as opposed to technological or process failures.
Ultimately, it is the responsibility of laboratory supervisors to understand that error prevention is a broad initiative. Corrective actions can involve the implementation of technology, enhanced training methods, more rigorous surveillance of practices, and better communication with staff. Creating an environment in which staff members are encouraged to express concerns and are open to such concerns will prove vastly beneficial to the laboratory operation as a whole.
- Clinical and Laboratory Standards Institute. Quality Management System: Continual Improvement; Approved Guideline—Third Edition. CLSI Document GP22-A3. Vol.31 No.14. Available at: www.clsi.org/source/orders/free/GP22-A3.pdf
Lynn Padley, MA, MT(ASCP), is the administrator of Quality Management Services and Practice in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota. She earned a BS in General Science and Medical Technology and is certified as a Medical Technologist by ASCP. Lynn has held multiple positions in quality management, including quality management coordinator, audit coordinator, and quality supervisor for anatomic pathology.
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